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CELL-DYN EMERALD SYSTEM - CLEANER REAGENT (2016-03-29)
- Starting date:
- March 29, 2016
- Posting date:
- July 4, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57846
Affected products
- CELL-DYN EMERALD SYSTEM - CLEANER REAGENT
Reason
They have identified occurrences where the CELL-DYN Emerald analyzer generates quality control (QC) out of range low for parameters RBC and PLT when using CELL-DYN Emerald cleaner lots# 6853, 6901, 6953, 6991, 7024, 7027, 7044, 7082, 7110 and 7119. Not all customers are experiencing this issue. Replacement of the CELL-DYN Emerald cleaner, along with a system cleaning of the instrument, must be performed in order to resolve the issue.
Affected products
-
CELL-DYN EMERALD SYSTEM - CLEANER REAGENT
Lot or serial number
- 6853
- 6901
- 6953
- 6991
- 7024
- 7027
- 7044
- 7082
- 7110
- 7119
Model or catalog number
- 09H46-02
Companies
- Manufacturer
-
Abbott Laboratories Diagnostcis Division
100 Abbott Park Road,
Abbott Park
60064
Illinois
UNITED STATES